Pfizer Inc announced the discontinuation of the Sun 1122 phase-3 trial that evaluated Sutent (sunitinib malate) plus FOLFIRI (irinotecan plus infusional 5-fluorouracil and leucovorin) versus FOLFIRI alone for the first-line treatment of metastatic colorectal cancer (CRC). The independent Data Monitoring Committee (DMC) found that the addition of sunitinib to the chemotherapy regimen FOLFIRI would be unable to demonstrate a statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared to FOLFIRI alone, in this study. No new safety issues were identified.

"We are disappointed with this result, but trial successes and failures are an integral part of cancer drug development and contribute to a growing body of knowledge on improving patient care," said Dr Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs for Pfizer's Oncology Business Unit. "Pfizer remains committed to developing new agents for colorectal and other GI cancers with ongoing clinical studies evaluating other agents in its pipeline. Investigators will be consulted about the status of sunitinib colorectal studies other than the Sun 1122 trial. Pfizer also continues to study sunitinib in late-stage trials as a potential treatment for various other types of cancer."

Pfizer has notified clinical trial investigators involved in the study and regulatory agencies of these findings.

These results do not affect the approved indications with sunitinib as monotherapy, where it has played a significant role in advancing the care of patients. Sunitinib is currently approved for both gastrointestinal stromal tumour (GIST) after disease progression on or intolerance to imatinib mesylate, and advanced / metastatic renal cell carcinoma (RCC) based on efficacy and safety data from large, randomized phase-3 clinical trials. To date, over 50,000 patients have been treated globally.

Sutent is an oral multi-kinase inhibitor approved for the treatment of GIST after disease progression on or intolerance to imatinib mesylate and advanced RCC.